- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07608237
Labral Repair vs Reconstruction
Labral Repair Versus Reconstruction in Symptomatic Femoroacetabular Impingement in Patients Over 40 Years of Age - A Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Femoroacetabular impingement syndrome (FAIS) is an increasingly common cause hip pain. It is known to cause labral pathology and if left untreated, can also contribute to the development of hip osteoarthritis. While non-operative treatment has been shown to be effective and can improve patients' quality of life, surgical treatment has often been shown to yield superior outcomes, while also potentially decreasing the future risk of osteoarthritis.
Mid- to long-term outcomes have shown durable results following hip arthroscopy with significant improvements in patient reported outcome measures (PROMs). Consequently, hip arthroscopy utilization has continued to increase. Several retrospective cohort studies have attempted to identify prognostic variables associated with procedural outcomes. In terms of patient selection, age has historically been identified as a negative prognostic variable, with inferior clinical outcomes observed in patients over the age of 40. However, more recent studies have disputed this finding, suggesting that earlier studies reporting this included patients with concomitant hip osteoarthritis, which was more to blame than their chronological age. Recent case series have reported significant improvements in PROMs in patients over the age of 40 who have minimal concomitant OA (Tönnis 0 or 1), with durable results out to 5 years14-16.
Despite these encouraging results, newer concerns have been raised when it comes to labral treatment in this demographic. It has been suggested that in patients over 40 years of age, the labrum may be too traumatized to allow repair or that it may have diminished healing capacity from repetitive impingement or age-related degeneration. As such, there have been proponents of performing a primary labral reconstruction in this patient population, with better associated outcomes. Others have reported equivocal outcomes between repair and reconstruction for this group. As such, there is no consensus on the best treatment strategy to manage these patients.
The results of this pilot study will allow the investigators to determine whether a full-scale study will be feasible. The investigators will not move forward with the full study: 1) if the proportion of eligible patients providing consent is <80%; 2) If the 95% confidence intervals around the difference between groups does not include even the possibility of a small, but important effect (0.2 SD); 3) if the proportion of patients completing their one-year follow-up is <85%, then the study is not feasible.
Ultimately, for the full-scale study, the investigators hypothesize that patients treated with labral reconstruction will have significantly better outcome scores compared with patients who underwent a traditional labral repair. If the hypothesized findings are true in the full study, this will change clinical practice patterns by providing objective evidence to guide treatment of labral pathology in patients over the age of 40 undergoing hip arthroscopy for FAIS.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Ontario
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London, Ontario, Canada, N6A 3K7
- Fowler Kennedy Sport Medicine Clinic
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Contact:
- Ashley Ambrose
- Numéro de téléphone: 87528 5196612111
- E-mail: ashley.ambrose@lhsc.on.ca
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Chercheur principal:
- Ryan Degen
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion:
-Cam or pincer morphology who have failed a trial of conservative treatment
Exclusion:
- Moderate concomitant OA (Tönnis 2+)
- Have had previous hip surgery
- Active joint or systemic infection
- Significant muscle paralysis
- Inflammatory arthropathies
- Significant medical comorbidity that may alter effectiveness of surgical intervention
- Active smoker
- Major medical illness
- Unable to speak and understand English
- Psychiatric illness that precludes informed consent
- Unwilling to be followed for 2 years
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Labral Repair
Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
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Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
|
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Comparateur actif: Labral Reconstruction
Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.
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Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
International Hip Outcome Tool (iHOT) - 12
Délai: Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Hip Outcome Score- Activities of Daily Living (HOS-ADL)
Délai: Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
|
|
Hip Outcome Score- Sport Specific Subscale (HOS-SSS)
Délai: Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
|
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modified Harris Hip Score (mHHS)
Délai: Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
|
|
EQ-5D
Délai: Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
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Cost Diary
Délai: 6 weeks to 2 years post surgical follow-up
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6 weeks to 2 years post surgical follow-up
|
|
Patient Satisfaction Scale
Délai: 6 weeks to 2 years post surgical follow-up
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6 weeks to 2 years post surgical follow-up
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Post-operative complication rates
Délai: 6 weeks to 2 years post surgical follow-up
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6 weeks to 2 years post surgical follow-up
|
|
Subsequent surgery rates
Délai: 6 weeks to 2 years post surgical follow-up
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6 weeks to 2 years post surgical follow-up
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 127777
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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